FDA · official record K892335Substantially Equivalent

ARGEDENT 74 DENTAL ALLOY FOR PORCELAIN APPLI.

Name: ARGEDENT 74 DENTAL ALLOY FOR PORCELAIN APPLI. — FDA K892335
Creator: Argen Precious Metals, Inc.
Keywords: ARGEDENT 74 DENTAL ALLOY FOR PORCELAIN APPLI., ARGEDENT 74 DENTAL ALLOY FOR PORCELAIN APPLI., K892335, EJT, FDA

United StatesEJTArgen Precious Metals, Inc.

Verified

Official record identity

FDA application number: K892335
Decision date: May 31, 1989
Published decision: Substantially Equivalent

Classification

Product code: EJT

Published parties

Applicant: Argen Precious Metals, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1989-04-05
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3060

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.